FDA to inspect Sputnik V factory in Russia next week

MANILA – A team from the Philippine Food and Drug Administration (FDA) is visiting Gamaleya Institute’s manufacturing facility in Russia next week for the anticipated emergency use authorization (EUA) of Sputnik V vaccine in the country.

This was disclosed by FDA Director-General Eric Domingo who confirmed on Wednesday an earlier report that the EUA may be granted to Sputnik V within the next two weeks.

“Two weeks is best-case scenario. Might extend if not all findings are compliant,” he told the Philippine News Agency (PNA).

Domingo said “a few documents” are still pending from Gamaleya but did not disclose what those were.

The Russian Embassy in Manila, meanwhile, said it continues to engage Philippine authorities to complete the necessary requirements for the EUA.

Earlier, Foreign Affairs Secretary Teodoro Locsin, Jr. shared that Manila may get up to 20 million doses of the Russian-made vaccine

“[I]n two weeks there’s the EUA for the Russian vaccine which could amount to another 20 million doses of the only Lancet peer-reviewed vaccine on the planet. Working on that,” he tweeted on Tuesday.

Sputnik V is the world’s first registered vaccine, with 91.6 percent efficacy against Covid-19 as validated by internationally peer-reviewed data published in the medical journal The Lancet.

This figure is based on the analysis of data on 19,866 volunteers, who received both the first and second doses of the vaccine or placebo at the final control point of 78 confirmed Covid-19 cases, according to Sputnik V’s website.